Scrutinizing the COVID-19 vaccine safety debate

ABSTRACT

The controversy surrounding the safety of coronavirus disease-19 vaccinations is part of a larger historical backdrop of ongoing discussions regarding vaccine safety that have spanned several decades. The historical disputes around measles, mumps, rubella, and influenza highlight the recurring pattern in which public doubt is fueled by false information and personal stories. A 2024 multinational study in the journal Vaccine presented preexisting safety indicators for myocarditis, pericarditis, Guillain – Barré syndrome, and cerebral venous sinus thrombosis. The study had a notably large sample size and contributed to the ongoing discussion of vaccine safety. Examining this research clarifies the subtle distinctions between demonstrating causality and simple association, emphasizing the importance of thorough scientific investigation and open communication. The following recommendations should be prioritized to tackle vaccine hesitancy and ensure that politicians, healthcare practitioners, and public health officials make informed decisions. Vaccine safety data should be openly and readily provided to the public, particularly regarding potential hazards and advantages. Establishing post-marketing surveillance systems to monitor and examine adverse effects linked to vaccinations helps strengthen public confidence in the safety monitoring process and officials’ dedication to addressing safety concerns with thoroughness.

KEY MESSAGES

• The controversy surrounding COVID-19 vaccine safety is part of a historical trend of doubts around vaccine safety.

• A 2024 study suggests a potential link between COVID-19 vaccinations and adverse outcomes, emphasizing the importance of thorough scientific investigation.

• Recommendations include providing safety data openly to the public and establishing postmarketing surveillance systems to address safety concerns and build confidence in vaccine safety.

Introduction

The worldwide rollout of COVID-19 vaccines marked a defining moment in humanity’s struggle with the pandemic. However, amid the success of vaccination programs has grown a strong controversy over vaccine safety, which threatens to cast shade on these new and necessary public health interventions. This controversy is, therefore, not just an academic question but a highly relevant debate that impacts public confidence, health policy, and global vaccination campaigns.

Core to this discourse is the 2024 study published in the journal Vaccine, a landmark research effort that examines a potential association between COVID-19 vaccines and severe cardiovascular outcomes.^1–3 The study is based on an enormous sample size of over 99 million people and has garnered significant attention and provoked controversy among the scientific community and the public.

Suppose the findings point toward myocarditis and sudden death related to the administration of the vaccine. In that case, the implications are enormous for public health strategies and vaccine deployment protocols worldwide.

As stakeholders grapple with the implications of these findings, questions abound regarding the study’s methodology, statistical robustness, and the broader narrative of vaccine safety. The present article puts these critical matters into perspective in the historical backdrop of vaccine safety debates, weighs in on the benefits and drawbacks of COVID-19 vaccines, looks into the methodology of the 2024 study, and explores the rationale behind vaccine skepticism before giving insight into how to navigate this complex terrain.

In bringing out this complexity, we aim for an in-depth analysis that empowers knowledgeable discourse and decision-making. This becomes crucial in steering through this global vaccination campaign that is still very much underway and riddled with uncertainties and only partial public trust.

Historical context of vaccine safety debates

Although the technique of inoculation began over 500 years ago, the name “vaccine” was officially coined in the 18th century by Edward Jenner. The word originates from the Latin vacca, meaning “cow.” In 1796, Jenner vaccinated an eight-year-old child by introducing material from cowpox lesions from the hands of a milkmaid. Figure 1 demonstrates the chronology of vaccines throughout history.

Figure 1.

The chronology of vaccines throughout history. Source: history of vaccines timeline. Understanding animal research; https://www.understandinganimalresearch.org.uk/resources/infographics/history-of-vaccines-timeline. Accessed 2024-08-09.

The history of vaccine safety debates is as old as scientific investigation and public health policy, tempered by societal perceptions. Throughout the years, vaccines have been touted as lifesaving interventions; at the same time, they have been scrutinized for their risks. Knowing the history of such debates provides insight into the origin of skepticism regarding vaccines and the scientific basis for vaccine safety assessments.

Historical precedents

The most well-known controversy related to vaccine safety is the measles, mumps, and rubella (MMR) vaccine. In 1998, a study by Andrew Wakefield and colleagues published in The Lancet suggested a possible link between the MMR vaccine and autism spectrum disorders.^4–6

This corresponded with general concerns about vaccines and precipitated a drop in vaccination rates in some countries. Further investigations discovered critical flaws in the study’s methodology and found several conflicts of interest; the study was withdrawn, and the findings were discounted. The episode underlined that despite firm scientific consensus on the safety of the MMR vaccine, misinformation or public perception could profoundly impact vaccination uptake.

A similar periodic safety concern arises about influenza vaccines. The formulation of vaccines changes annually, based on the expected circulating viruses. In pandemic situations, such as the 2009 swine flu (H1N1) pandemic, the manufacturing process needs to be scaled up incredibly quickly.^7–10

This has led to many concerns over the safety and efficacy of these vaccines. However, vaccine safety surveillance systems have invariably demonstrated an overall safety profile for the seasonal and pandemic influenza vaccines that is consistent with their crucial role in preventing severe illness and death.

Scientific foundation versus non-scientific views

Vaccine development must adhere to strict principles of safety and efficacy. Vaccine candidates are tested in the laboratory through preclinical studies, while clinical trials test the safety and immune response in human volunteers.¹¹ Regulative agencies, like the Food and Drug Administration in Europe, only sanction drugs if the data undergo a proper review with complete safety and efficacy profiles.

Post-licensure surveillance can go one step further, with a continued assessment of vaccine safety in real-world settings, where combinations and rare events which might have been obscured in clinical trials are more likely to appear.¹¹ The Vaccine Adverse Event Reporting System (VAERS), along with other US and worldwide systems for continuous monitoring, provide a fundamental feedback loop for regulatory decisions and public health interventions by constantly evaluating the safety of the vaccines.^12,13

Scientific consensus overwhelmingly supports the benefits of vaccines in preventing infectious diseases and associated morbidity and mortality.^11,14,15 Vaccination has eradicated smallpox, nearly eliminated polio in most regions, and lessened considerably the world burden of measles and influenza.¹⁶

Non-scientific views and misinformation

Even in the face of robust scientific evidence, vaccine skepticism prevails for several reasons. Misinformation relayed through social media, anti-vaccine advocacy organizations, and personal testaments undermines public trust in vaccines.^17,18 Conspiracy theories of harm from vaccines or governmental cover-ups can take advantage of existing uncertainties in a population to instigate doubts about vaccination.^19,20

Weighing benefits of immunization

A groundbreaking study recently published in The Lancet finds that worldwide vaccination initiatives have preserved approximately 154 million lives, comparable to saving six lives per minute for the past 50 years. The overwhelming majority of these saved lives were children, including 101 million infants.¹⁶

The research, spearheaded by the World Health Organization (WHO), demonstrates that immunization is the most significant contribution of any health intervention in guaranteeing that infants survive their first year and maintain good health throughout their adult lives.

Among the vaccines examined in the study, the measles vaccine had the greatest effect on decreasing infant mortality, saving 60% of lives through immunization. This vaccination is expected to continue being the primary factor in preventing fatalities in the future.²¹

Vaccination against 14 diseases, including diphtheria, Haemophilus influenzae type B, hepatitis B, Japanese encephalitis, measles, meningitis A, pertussis, invasive pneumococcal disease, polio, rotavirus, rubella, tetanus, tuberculosis, and yellow fever, has significantly decreased infant mortality rates. Globally, infant deaths have been reduced by 40%, and in the WHO African Region, the reduction is over 50%. “Vaccines are one of the most potent innovations in human history, as they can prevent diseases that were once feared,” stated Dr. Tedros Adhanom Ghebreyesus, the Director-General of WHO.²² Vaccines have played a crucial role in eradicating smallpox and bringing polio to the verge of elimination. Furthermore, the development of vaccines against diseases such as malaria and cervical cancer has allowed significant progress in combating these illnesses. Through ongoing study, investment, and collaboration, we have the potential to preserve millions more lives both now and in the upcoming half-century.

The study revealed that each immunization saved one life and acquired an average of 66 years of optimal health. Over the course of five decades, a cumulative total of 10.2 billion years of complete health were obtained.²³

Thanks to the polio vaccine, almost 20 million individuals have been spared from paralysis and are now capable of walking. Furthermore, the global community is on the brink of eliminating polio. The improvements in childhood survival underscore the importance of safeguarding advancements in immunization worldwide and expediting endeavors to reach the 67 million children who were deprived of one or more immunizations during the years of the epidemic.^24,25

Canadian vaccination program

Immunization is a fundamental pillar of Canada’s healthcare system, averting millions of cases of infectious diseases. Vaccines effectively prevent emerging health risks like severe acute respiratory syndrome (SARS), West Nile virus, avian influenza, evolving strains of the influenza virus, and potentially other diseases such as diabetes and cancer. Vaccinations are crucial in preserving human lives. “Proactively taking measures to prevent a problem is more valuable than finding a solution after the problem has occurred.” Currently, around 25 infectious diseases can be prevented with vaccination.^26,27

Vaccines are a cost-effective, relatively affordable health intervention compared to the long-term care needed for disease treatment.²⁸ Canadian expenditures on vaccines constitute less than 0.17% of the yearly healthcare budget, as the Public Health Agency of Canada (PHAC) reported in 2007 and the Canadian Institute for Health Information (CIHI) in 2006.²⁹

Public funding is crucial for attaining high immunization rates. Each dollar allocated to immunization against measles, mumps, and rubella saves over three times that amount in healthcare expenditures. Vaccination against these illnesses in Canada results in an annual cost savings of $88 million in treatment expenses and prevents the loss of approximately 420,000 lives per year.³⁰

Vaccination typically confers benefits not only to the individual but also to the entire population. For instance, administering complete vaccination rounds to babies to protect against invasive pneumococcal infection has resulted in a significant reduction of 75.1% in this infection among individuals aged 65 years or older.³¹

Australian vaccination program

A study titled “The Burden of Vaccine-Preventable Diseases in Australia” assessed the current and future impact, including premature mortality, of newly identified instances of diseases that can be prevented with vaccines offered by the National Immunization Program. The study revealed a reduction of around 33% in the disease burden rate between 2005 and 2015. The decline was caused mainly by reductions in the incidence of diseases for which vaccines had been implemented during the last two decades, including human papillomavirus (HPV), pneumococcal disease, and rotavirus. The prevalence of burden significantly declined among babies, children, adolescents, and young adults – age cohorts that are the primary target of national and regional immunization initiatives.³²

Weighing benefits and drawbacks of COVID-19 vaccines

Although the COVID-19 epidemic has negatively impacted society, vaccine acceptance is far from universal. Global concern is rising in regard to vaccine reluctance, which has been attributed to several factors, including fear of vaccine composition, adverse effects, and lack of sufficient knowledge about the vaccine.^33,34 The vaccine’s success against the virus heavily depends on the number of people who choose to receive it. Researchers have demonstrated that vaccine reluctance varies worldwide, with the European region exhibiting the lowest level of trust in vaccination safety.³⁵

Benefits of COVID-19 vaccines

The COVID-19 vaccine rollout has brought immense gains to public health, primarily in reducing morbidity and mortality directly linked to the SARS-CoV-2 virus. Data from both clinical trials and the wider vaccinated population illustrate high effectiveness against symptomatic infections and severe outcomes of COVID-19, such as hospitalization and death.^36–38 Moreover, viral loads among vaccinated individuals are lower, lowering transmission rates, a critical factor in community immunity.³⁹

Efficacy against COVID-19

Vaccines developed against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have shown efficacy rates of more than 90% against symptomatic COVID-19 for multiple vaccine platforms, such as the messenger ribonucleic acid (mRNA)-based vaccines of Pfizer – BioNTech and Moderna and the viral vector vaccine candidates of AstraZeneca.³⁶ This represents a considerable reduction in severe illness and related healthcare burdens.⁴⁰

The COVID-19 vaccination campaigns have, therefore, allowed a better public health response by enabling governments to safely loosen stringent and burdensome public health measures and reopen economies.^36,41

Successful vaccination campaigns also assist in herd immunity, protecting vulnerable populations from the disease, especially those whose vaccination may not elicit a strong enough immune response if introduced.⁴²

Beyond the immediate control of the pandemic, COVID-19 vaccines have possible long-term health benefits, including prevention of post-acute sequelae from SARS-CoV-2 infection, such as long COVID, and avoiding future waves of infections that can put heavy burdens on healthcare systems.⁴³

SARSCoV2 vaccines significantly reduce the risk for COVID-19 associated hospitalization in older adults and, in turn, might lead to commensurate reductions in post-COVID conditions and deaths.⁴⁴ (See Figures 2 and 3)

Figure 2.

Intensive care unit full of SARS-CoV-2 patients before the discovery of SARS-CoV-2 vaccines.

Figure 3.

Intensive care unit almost empty of SARS-CoV-2 patients after the discovery of SARS-CoV-2 vaccines.

Safety concerns

During deployment, COVID-19 vaccines were underlain with rigorous safety monitoring to detect and evaluate adverse events potentially related to vaccination. While most vaccinated persons present only mild or moderate side effects, such as pain at the injection site, fatigue, or fever, concerns have been raised regarding severe adverse events of low occurrence.³⁶ This section presents documented adverse events and weighs them against their statistical significance within the general context of vaccine safety.

Documented adverse events

Myocarditis and pericarditis are among the most closely monitored adverse events associated with COVID-19 vaccination. These mainly occur in young males a few days after the second dose of mRNA vaccines like Pfizer – BioNTech and Moderna. Regulatory agencies remark that, according to vaccination history, cases of myocarditis and pericarditis have been reported but remain uncommon and typically result in mild illness.⁴⁵ For example, the US Centers for Disease Control and Prevention (CDC) reports approximately 12.6 cases per million shots of mRNA COVID-19 vaccines administered to males between the ages of 16 and 29 years.

Rare cases of thrombosis with thrombocytopenia syndrome (TTS) have been associated with some adenovirus vector-based COVID-19 vaccines, in particular, AstraZeneca and Johnson & Johnson.⁴⁶ TTS is a blood clotting disorder that co-occurs with a low platelet count.⁴⁵ So far, it has mainly affected young females. Health authorities have recommended monitoring and managing this rare but serious adverse event.⁴⁷

Statistical significance and risk assessment

In considering COVID-19 vaccine-related adverse events, the statistical significance and risk-benefit profile are relevant as well:

Risk-benefit assessment

Regulatory authorities, like the Food and Drug Administration (FDA) and the CDC in the US, maintain safety monitoring systems that involve assessment of the overall risk-benefit balance of COVID-19 vaccines.⁴⁵ Even against the backdrop of rare adverse events, vaccination holds great value for most people in preventing severe illness from COVID-19 and all its complications.⁴⁸

Post-marketing surveillance

Robust pharmacovigilance systems are in place to monitor and investigate adverse events following immunization. Continuous monitoring and analysis of real-world data will enable health authorities to promptly respond to any emerging safety signal and update recommendations if needed.⁴⁹

A recent study modeled the benefit-risk ratio for every one million individuals receiving both doses of the Moderna mRNA COVID-19 vaccine. The benefit endpoints included COVID-19 instances, hospitalizations, admissions to intensive care units (ICUs), and deaths that the vaccine could have prevented. The objectives for assessing risk were cases of myocarditis/pericarditis, hospitalizations, admissions to the ICU, and deaths due to the vaccination (Figure 4).

Figure 4.

The benefits versus drawbacks of moderna’s CVmRNA vaccine. Source: benefit-risk assessment of covid-19 vaccine, MRNA (MRNA-1273) for males aged 18-64. Vaccine X. 2023 Aug; 14:100325.

The findings substantiated the assertion that the advantages of the vaccine surpass its drawbacks. They observed that if one million males aged 18–25 were vaccinated during the pandemic, it would have prevented 82,484 cases, 4,766 hospitalizations, 1,144 ICU admissions, and 51 deaths caused by COVID-19. In comparison, the vaccine would cause 128 cases of myocarditis/pericarditis, resulting in 110 hospitalizations, zero ICU admissions, and zero deaths. The study was limited by uncertainties regarding the pandemic’s trajectory, the vaccine’s efficiency against new variations, and the rate of vaccination-related myocarditis/pericarditis. Furthermore, the model does not assess the possible long-term negative consequences caused by either COVID-19 or vaccine-related myocarditis/pericarditis (Figure 5).⁵⁰

Figure 5.

Six bar graphs examining benefits (e.g., prevented deaths) and risks (e.g., excess deaths) per million males aged 18-45 years.

Source: Benefit-risk assessment of COVID-19 vaccine, MRNA (MRNA-1273) for males aged 18-64 years. Vaccine X. 2023 Aug; 14:100325.

Critique of the 2024 study on COVID-19 vaccine safety

Methodology overview

The 2024 study in the journal Vaccine contributes significantly to the discourse regarding the safety of COVID-19 vaccines, due mainly to its robust methodological framework. Its retrospective cohort design was based on real-world data on more than 99 million people.¹ Any dataset of this enormous size has the potential for high statistical power to detect an association, if any, between COVID-19 vaccination and adverse events. Methodologically, the study employed advanced epidemiological designs that enhanced its internal validity, including propensity score matching with adjustment for some confounding variables in the analysis. Despite these strengths, critics may still raise concerns that the study was based on secondary healthcare databases, introducing another source of bias related to data completeness and accuracy.

Causality contrasted with association

The critical distinction of the research findings concerns association versus causation regarding adverse events following COVID-19 vaccination. Even though statistically significant associations of vaccination with outcomes such as myocarditis and pericarditis are detected within the stratum under investigation, stringent criteria must be fulfilled to confirm causality, including temporality, biological plausibility, and reproducibility across several settings.^1,13,51

Some critics argued that the observational data in this study failed to establish causality. Further, the potential impact of unmeasured confounders or biases in observational studies indicates that reported associations should be interpreted cautiously.^52,53

Criticism and validation

This 2024 study rose to prominence due to its pivotal implications for public health policy and vaccine safety. Research independent of the authors and regulatory agencies is underway to conduct a thorough peer review and validation of the study’s processes to allow transparency and reproducibility in scientific inquiry.^1,54

The study has validity concerns related to methodological limitations, including its retrospective data collection and inherent biases in database analyses. However, it provides insight into rare adverse events associated with COVID-19 vaccination, and proponents argue that it should be interpreted with nuance within the broader context of global immunization efforts.

Motivations behind vaccine skepticism

In identifying the stakeholders and motivations behind the promotion of vaccine skepticism, a broad swath of actors and diverse agendas emerge. Both anti-vaccine advocacy groups and individual advocates have taken up the task of spreading misinformation and sowing seeds of distrust against vaccines.⁵⁵

These anti-vaccine advocates may be groups or individuals who espouse theories regarding the safety of vaccines due to personal anecdotes or misinformation found on social media platforms.⁵⁶ Indirectly, skepticism can also be engendered by pharmaceutical companies and health providers who are likely to gain by selling treatments or alternative health products against the mainstream vaccines.⁵⁷

The diverse roles of social media in disseminating information to the general public, along with the behavior of persons on social media during public health events, highlight the potential of social media as a platform for public health intervention to tackle vaccination hesitancy and promote safety.⁵⁸

It is crucial to distribute accurate and verified information regarding the COVID-19 vaccines through social media platforms to enhance public confidence and mitigate the influence of erroneous misinformation.⁵⁹

A recent systematic review and meta-analysis were conducted to consolidate the current studies on the dissemination of disinformation regarding COVID-19 vaccinations on social media platforms and its subsequent impacts. The analysis yielded 757 papers. Out of these, 45 articles were chosen specifically for the review. The review delineated three primary themes of misinformation: medical misinformation, misinformation about vaccine development, and conspiracies. Twitter (now “X”) was the primary subject of study among social media platforms, with Facebook, YouTube, and Instagram being subsequent study subjects. The overwhelming bulk of studies originated from industrialized Western nations. The researchers identified 19 papers that examined or explored the impact of social media disinformation on vaccine reluctance. Disseminating false information on social media reduces people’s willingness to receive vaccines and subsequent vaccine uptake.⁶⁰

Saudi Arabia has successfully utilized big data and artificial intelligence to control the COVID-19 pandemic and track its progress. This achievement is exemplified by the launch of several user-friendly applications, such as the Tawakkalna app, the Spacing application, the Sehati (My Health) app, and others. These applications have proven to be highly valuable in monitoring COVID-19 cases, tracking their progression, and monitoring the side effects of vaccines – advantages that aided in managing and reducing the impact of the epidemic.^61–63

The Saudi Ministry of Health initiated the national vaccine registry (NVR) system to document the vaccines administered, their specific type, and the number of doses given, linked to the medical history of citizens and residents.⁶⁴

Since initiating the Saudi Arabian COVID-19 vaccination program, the populace has expressed divergent viewpoints regarding the vaccine. Two prior assessments on accepting COVID-19 vaccines revealed a 45% acceptance rate among 3,101 participants and a 65% acceptance rate among 992 participants.^65,66 Two-thirds (70%) of healthcare professionals had confidence in the safety of vaccines.^64,67

Timing and context

Several factors have interacted to center vaccine safety concerns during the pandemic. First, the high-speed development and emergency authorization of COVID-19 vaccines immediately caused fear in the population’s mind about the safety and long-term effects of such vaccines.^56,68,69 It is a concern justified by science and rigorous monitoring, but vaccine development and approval happened at an unprecedented pace, resulting in misgivings that scientists had compromised safety protocols and long-term testing.

Second, the politicization of public health responses, particularly mask mandates and vaccination campaigns, polarized public opinion and further amplified existing skepticism toward vaccines.⁷⁰

Moreover, long before the vaccination campaigns, misinformation and conspiracy theories had been present on social media, labeling the inoculation requirement as an infringement on individual freedom.⁵⁶

The pandemic further exposed latent inequities in healthcare accessibility and trust in the medical institution. It fundamentally affected minority groups who already faced many structural barriers to health care. Finally, it showed how historical incidents of medical misconduct and unethical experimentation have fed into a far-reaching cultural skepticism of authoritative health recommendations.⁷¹

Conclusions and recommendations

Discussions of safety in COVID-19 vaccines fall into a broader historical context of decades-long discussions concerning vaccine safety. Historical precedents of controversies over MMR and influenza vaccines underline a repetitive structure in which public skepticism is often fanned by misinformation and anecdotal evidence.

Informed opinion on this issue continues to fuel further debate, such as the 2024 study in Vaccine, which utilized its enormously large sample size to examine potential links between COVID-19 vaccines and adverse events such as myocarditis and sudden death.⁵⁶ Analyzing this study can help to elucidate the fine line between establishment of causality and mere association, a principle that is fundamental to rigorous scientific scrutiny and open communication.

Policy and public awareness

In this regard, the following recommendations must be seriously considered and implemented as a priority to address vaccine hesitancy and ensure effective, informed decision-making by policymakers, healthcare providers, and public health officials. Vaccine safety data, specifically the potential risks and benefits, should be transparently and accessibly communicated to the public.

Construction or improvement of post-marketing surveillance systems to track and investigate the adverse events associated with vaccines can further enhance public trust in both the safety monitoring mechanism and the commitment to tackling rigorously raised safety concerns.^72,73

As with any pharmaceutical intervention, though rare, some adverse effects will inevitably result from vaccinations. Nevertheless, since vaccines are primarily administered to healthy individuals and in large numbers, it is imperative to establish a system that can promptly evaluate the equilibrium between a vaccine’s advantages and drawbacks. Therefore, it is essential to consistently monitor the safety of a vaccination to identify and assess any infrequent negative occurrences, and enable a reassessment of the trade-off between the advantages and drawbacks of the vaccine. The primary objective of most post-approval vaccination safety monitoring systems is to prioritize the reporting of unforeseen side effects.¹²

With the advancement of digital health systems, an increasing array of methods is available to monitor vaccine safety. For example, the US has utilized extensive, networked data sources to oversee vaccine safety. As a result, a partnership was formed between the CDC and health maintenance organizations to develop a vaccination safety data connection.^74,75

Finally, building trust requires understanding and addressing specific community concerns and barriers to vaccination. Public health efforts must, therefore, engage in culturally competent and empathetic outreach programs with communities, particularly those historically marginalized or disproportionately affected by vaccine misinformation.^72,76

Biography

Khalid Bin Abdulrahman is a professor of family medicine and medical education. He completed his medical education at King Abdulaziz University in 1988. In 1993, he obtained his board certification in family medicine, and in 1999, he completed an academic fellowship and earned a master’s degree in medical education from the University of Toronto. He served as the inaugural dean of the School of Medicine at Imam Mohammed Ibn Saud Islamic University (IMSIU). He previously served as the vice-rector of IMSIU, with responsibilities in planning, development, and quality assurance. He is a founding member of the ASPIRE Award, an international recognition program that honors excellence in medical education. Prof Khalid has authored over 100 publications in family medicine and medical education, which have been published in local and international peer-reviewed journals. He has delivered over 500 talks at local, regional, and worldwide conferences. He was awarded the certificate for editorial excellence by The Association of Medical Education in Europe (AMEE) during the AMEE conference in Milan on September 2, 2014. He is the inaugural editor of the internationally acclaimed book “The Routledge International Handbook of Medical Education, 2016 Edition.”

Funding Statement

This research received no external funding.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Author contributions

All authors participated in the concept, design, analysis, interpretation of data, writing, and manuscript review. They have seen and approved the final version of the manuscript.